Where We Hear From the NY Post And We Are Left Wondering What It "All" Means...Er, "Means"

After noticing several factual inaccuracies about Plan B in a NY Post op-ed, I emailed the columnist:

Ms. Wisse Schachter,

I'm contacting you to alert you to a number of factual mistakes in your op-ed. Briefly:

--Plan B is the "emergency contraception pill[s]", or the "postcoital pill[s]", not the "morning-after pill". [That's an incorrect and misleading term.]

--Plan B is not a pill, it's two pills. Two 0.75 mg levonorgestrel pills, to be exact. [Essential information in view of the new dosage recommendations.]

--Plan B is not basically a double dose of the regular birth-control pill. [Even without defining "regular birth-control pill", Plan B is neither a double dose of the regular progestin-only pill, nor of the EC regimen combination one.]

--Plan B is not associated with "cardiovascular disease, high blood pressure, blood clots, heart attack and strokes." (For that matter, neither are the COC EC regimens.) [In fact, Plan B is the preferred EC method for patients with a history of blood clots or stroke.]

(Full post here.)

Thank you for your time.

ema

Today, Ms. Schachter emails back:

Dear Ema,

Thank you for your message and for taking the time to read and respond to my op-ed.

The side effects listed in my piece are those commonly associated with taking birth control, as I make perfectly clear.

It would have been nice had taken as much time reading the column as you did "rebutting" it.

Regards,
Abby Schachter

First, I appreciate the response.

Second, allow me to address this:

It would have been nice had taken as much time reading the column as you did "rebutting" it.

People, as a rule, when emailing me, assume I'm dense and just say what you mean. Not having to divine intent saves me a lot of time.

I'm not sure, but here's what I think Ms. Schachter's admonition means--"I write a piece focused on the political and social implications of OTC availability of Plan B, and you 1) don't address those issues at all, and/or 2) refute them [not] by pointing out, and correcting, the factual mistakes about Plan B." Correct and incorrect at the same time.

Correct, because all I did was address the factual mistakes about Plan B--what it is, it's side effects, etc. My position (and concern) is that, unless we know the basics about a drug, we cannot have an informed discussion about the politics surrounding it.

Incorrect, because, by pointing out the mistakes about Plan B, I was not rebutting anything; I wasn't presenting any opposing evidence to Ms. Schachter's opinions. The facts about Plan B, like its progestin-only content, are not up for debate. It's not a "she said", "she said" situation. We don't each get a few minutes to make our case. Plan B's composition, or side effects for that matter, are a given, independent of anyone's argument/counterargument [you know, the "science" part].

Last, but not least, we have this:

The side effects listed in my piece are those commonly associated with taking birth control, as I make perfectly clear.

Here's the thing [yes, I know, I'm watching way too much Monk]: 1) the side effects listed in the piece are not those commonly associated with taking birth control, and 2) there's nothing even remotely clear [not to mention correct] about Plan B's side effects in the piece.

There are seven groups of birth control, and over eighty individual methods:

1. Hormonal Group

-Combination Pill

-Progestin-only Pill

-Skin Patch

-Vaginal Ring

-Implants

-Shots

-[Hormone-releasing IUDs]

2. Nonsteroidal Pill Group

-Centchroman

3. Intrauterine Device Group

-Older IUDs

-Frame IUDs

-Frameless IUDs

-[Hormone-releasing IUDs]

4. Barrier and Spermicide Group

-Condom (male, female, and unisex)

-Diaphragm

-Cervical Cap

-Ovès Cap

-FemCap

-Lea contraceptive

[Good pics here.]

-Sponges

-Spermicides

5. Natural Family Planning Group

-Continuous Abstinence

-Outercourse

-Sexual techniques

-Breastfeeding

-Fertility Awareness

6. Sterilization Group

-Male

-Female

7. Emergency Contraception Group

-Combination Pill

-Progestin-only Pill

-Antiprogesterone Pill

-Progesterone production blocker Pill

-IUD

These are the side effects listed in the op-ed:

...mild, such as dizziness, weight gain and irregular periods. ... more serious, if rare - cardiovascular disease, high blood pressure, blood clots, heart attack and strokes.

Ms. Schachter says these are the side effects (emphasis mine) commonly associated with taking birth control. Since we're talking about common side effects, everything after rare (cardiovascular dz, HTN, blood clots, heart attack and strokes) is out.

So we're left with dizziness, weight gain and irregular periods. According to Ms. Schachter, these are the side effects commonly associated with taking birth control. Really? When's the last time your partner's condom use caused you to gain weight?

Okay, I'm being facetious, but you get the point. There's no such thing as side effects ... commonly associated with taking birth control. That's because a method's side effects depend on group, mode of action, dosage, route of administration, risk factors, etc..

Even if Ms. Schachter was only referring to the Hormonal Group when listing the side effects, it's still essential to be accurate.

Cardiovascular disease, high blood pressure, blood clots, heart attack and strokes are not common side effects of methods in the hormonal birth control group. They are rare effects of some of the methods--the combination (estrogen + progestin) ones--in this group. [To give you an idea ...even deaths due to rare events, such as accidents or homicides, are much more common than deaths due to OC-related adverse events.*]

Moreover, the Hormonal Group and the EC Group are not one and the same. The side effects associated with combination methods in the Hormonal Group differ from those associated with combination methods in the EC Group. Cardiovascular disease, high blood pressure, blood clots, heart attack and strokes are not side effects--rare or otherwise--associated with combination (estrogen + progestin) EC regimens. [From my previous post: No deaths or serious complications have been causally linked to emergency contraception.]

Last, but not least, Plan B is a PROGESTIN-ONLY method. Its side effects differ from the combination (estrogen + progestin) methods in the EC Group.

Which brings us to Ms. Schachter's assertion that she made it perfectly clear in her piece that the side effects she lists are commonly associated with (?hormonal/?estrogen-progestin) birth control, in general, not Plan B. I disagree, and here's why.

In a piece

...titled 'PLAN B': What Science Can't Tell Us...

...containing the statement But it plainly is all about Plan B...

...focused on issues surrounding the approval of OTC sales of Plan B...

...stating that OTC approval of Plan B is troubling because women could get it without the benefit of a doctor's warning about side effects...

Well, approval raises a host of troubling questions. For one: Since it's only a double dose of regular birth control, women over 18 (or girls with fake IDs) could get "the pill" without a prescription - or a doctor's warnings about side effects.

...personalizing the issue of lack of physician counseling about side effects, if Plan B becomes available OTC, by quoting an Ob/Gyn's concerns about losing the opportunity to present medical issues associated with OTC sales of Plan B...

Medical professionals have doubts. Dr. Vivian Roston, an OB-GYN at St. Luke's Roosevelt Hospital, worries that over-the-counter access to emergency contraception [that would be Plan B] means she won't have the chance to educate her patients. "I wouldn't want someone not to have access [to emergency contraception]," she told me. "But then again, you lose the opportunity to present all the medical issues associated with taking a high-dose hormonal drug" [again, Plan B] if a woman doesn't have to see a doctor to get it.

(emphasis mine)

...where the above paragraph--about Dr. Roston's worries that OTC sales of Plan B would rob her of the opportunity to discuss with women medical issues associated with taking Plan B--is immediately followed by an enumeration of side effects...

Of course, some of the risks are mild, such as dizziness, weight gain and irregular periods. But others are more serious, if rare - cardiovascular disease, high blood pressure, blood clots, heart attack and strokes.

it is not at all perfectly clear that the listed side effects are not those associated with Plan B, but rather those associated with some mythical "birth control".

Bottom line: This is not about Ms. Schachter's opinions on OTC sales of Plan B, or my reading comprehension and/or debating prowess. It's about the duty of a publication like the NY Post to present factually accurate medical information to its readers. Or not; in which case the NY Post should have no objection to publishing my article entitled "Plan B Causes Cooties."


*Dialogues In Contraception. Winter 2002;7(7):4

Skip Your Period and Period Control Options

Good AP article on the available options for period control, as well as some coming attractions.

Among the existing methods:

- Seasonale: 30 μg of estrogen (ethinyl estradiol, or EE)/150 μg of progestin (levonorgestrel), taken continuously for 84 days, followed by 1 week off.

- Ortho Evra patch: 0.75 mg estrogen (EE)/ 6.00 mg progestin (norelgestromin) [20 μg estrogen/150 μg progestin per day], one patch per week for 8 or 12 weeks in a row, followed by 1 week off.

- NuvaRing vaginal ring: 2.7 mg estrogen (EE)/11.7 mg progestin (etonogestrel) [15 μg estrogen/120 μg progestin per day], one ring in place for 3 weeks at a time, for 6 or 12 weeks total in a row, followed by 1 week off. [Alternatively, one ring can be left in place for 4 weeks at a time.]

- Depo-Provera [and Depo-subQ provera 104] shot: 150 mg progestin (medroxyprogesterone acetate) [104 mg progestin], one injection four times a year.

One more existing brand worth mentioning is Loestrin 24 Fe. The innovation here is the shortened placebo interval--one estrogen/progestin pill taken for 24 days, followed by one iron-containing placebo pill taken for 4 days. [Of course, if you're already taking the Pill, and you want a shorter placebo interval, you can use your existing brand to do that. Just take 4 placebo pills, instead of the usual 7, followed by a new pack.]

And some newer developments:

- Seasonique: 30 μg of estrogen [EE]/150 μg of progestin [levonorgestrel]), and 10 μg EE, one estrogen/progestin pill taken continuously for 84 days, followed by one estrogen-only pill for 7 days; no placebo interval.

- Lybrel: 20 μg ethinyl estradiol/90 μg levonorgestrel, one estrogen/progestin pill taken daily with no placebo intervals.

- Implanon*: 68 mg progestin (etonogestrel) [~40 μg progestin per day], one-rod implant lasting up to 3 years.

*Just like so many other methods before it (Mirena, Depo-Provera), Implanon has been available for over a decade outside the U.S.. This pretty much insures Implanon's status as a "cutting edge" method over here.

Surrogate Markers and Clinical Risks of Contraceptive Use

Another good article from Contraception: Is some of the information on contraceptive risks in the package inserts accurate and useful, or is it a barrage of innuendo and pseudo-science?

The development of safe and effective contraceptive options for women is the direct result of advances in laboratory-based research, which has provided an important foundation for the development of an evidence-based approach to contraceptive management. This marriage of laboratory and clinical investigation has not only served to better delineate pathophysiological processes but also has expanded our understanding of the mechanisms of therapeutic actions. However, when laboratory-based studies alone are used to explain clinical outcomes, prediction of clinical outcomes can be corrupted by a lack of clinical information and replaced by a process replete with unsupported assumptions, premature declarations and unfounded concern about the safety and effectiveness of therapeutic interventions. Such a disingenuous application of high-quality laboratory investigation is unfortunately now more commonly used to predict clinical risks of contraceptive use. In several instances, warnings and specific language have been included in the package inserts of contraceptives based on nonclinical studies.

Nonclinically based outcome variables, or surrogate markers, are studied to ostensibly better understand the pathophysiological basis of clinical outcomes associated with the use of particular drugs or therapeutic interventions. However, when such surrogate markers are studied to predict clinical outcomes in the absence of data assessing clinical outcomes, they may lead to unsubstantiated clinical predictions. An example of a surrogate marker and its inappropriate application for predicting clinical outcomes is the measurement of the size and number of ovarian follicles among users of oral contraceptive pills. Those pills associated with more numerous and larger ovarian follicles are "assumed" to be less potent and thus place a woman at a potential increased risk for pregnancy while using that pill. However, the presence or absence of follicles has never been actually correlated with contraceptive pill efficacy. Only a direct determination of pregnancy rates among users of specific contraceptive methods can provide meaningful information about the actual effectiveness of a given contraceptive.

Other examples of using surogate markers to predict risk:

Depo-Povera shot and the risk of bone fracture

In the past, the language of the package insert and all emboldened and boxed warnings communicated well-defined clinical risks, such as the increased risk of adverse cardiovascular events in women who smoke and use estrogen-containing oral contraceptives after the age of 35. Unfortunately, the language and warnings of package inserts have increasingly incorporated surrogate marker studies to arrive at pronouncements of clinical risk. For example, a black box warning in the package insert of Depo-Provera CI warns that the use of the product will diminish the calcium stored in bones and that this could cause an increased risk of fracture. Have studies consistently shown reduced bone mineral density among women using Depo-Provera CI? Yes, studies of a wide spectrum of women using Depo-Provera CI have consistently demonstrated reduced bone mineral densitometry measurements among Depo-Provera CI users. But has there been any study that has demonstrated an increased risk of fracture among any women (pre- or postmenopausal) using Depo-Provera CI? The answer is no. The measurement of bone mineral density in reproductive-age women is a surrogate marker with no known clinical relevance. Moreover, the suggestion that women should consider using an alternative method after 2 years of Depo-Provera CI use is not based on scientific or clinical evidence and may cause clinicians to inappropriately switch their patients to less effective contraceptives. Such changes will place women at increased risk for unintended pregnancy and induced abortion.

Finally, the language of the Depo-Provera package insert also suggests that clinicians "test the bones" of women who wish to continue this method for more than 2 years. As bone densitometry has been shown to be ineffective and inappropriate for assessing fracture risk in the vast majority of premenopausal women, what test is being suggested?

The Ortho Evra patch and the risk of serious adverse events

Unfortunately, this trend in drug warnings continues with the recently added language and new warnings incorporated into the package insert of the transdermal patch Ortho-Evra®. The new emboldened warning for Ortho-Evra is not based on studies of clinical outcomes, but rather nonclinical pharmacokinetic studies that have found that women who use the transdermal contraceptive patch have a greater overall exposure (approximately 60%) to ethinyl estradiol than those women who use a conventional oral contraceptive with 35 μg ethinyl estradiol. A recent study by van den Heuvel et al. compared the exposure to ethinyl estradiol among users of the transdermal patch, the vaginal ring (Nuva Ring) and an oral contraceptive containing 30 μg ethinyl estradiol and 150 μg levonorgestrel (Microgynon), and found that although women using the oral contraceptive had higher peak serum levels of estradiol than the other two agents, users of the transdermal patch had an overall higher exposure to estrogen (AUC or "area under the curve") than users of the other two formulations. The authors state that a lower exposure to ethinyl estradiol is desirable because of reduced "estrogen-related side effects..."

However, the term "estrogen exposure" that is used in the above study is actually a surrogate marker that the authors are using to predict the risk of estrogen-related adverse events with these products. No epidemiological data exist that demonstrate that the use of Ortho-Evra® results in higher rates of estrogen-associated adverse outcomes such as thromboembolic events. It is essential to have epidemiological information derived from rigorously performed clinical trials to make such clinical predictions. In the case of the three agents studied, the different doses and delivery systems likely are important for determination in the actual contraceptive effectiveness and safety. To this end, what if the peak concentration of ethinyl estradiol associated with the use of a contraceptive (Cmax) turns out to be the most important predictor of adverse outcomes instead of the area under the curve? Only epidemiological data will provide an accurate comparison of clinical risks between transdermal and other contraceptives. In fact, the new language in the Ortho-Evra® package insert specifically states that it is not known whether the pharmacokinetic differences are associated with an increase in the risk of serious adverse events in women using the contraceptive patch compared with women using oral contraceptives containing 35 μg ethinyl estradiol. If the package insert is meant to provide clinical warning concerning the use of a particular drug, this statement, which appears in various forms throughout the package insert, truly defies logic.

Women who use Ortho-Evra®, or any other estrogen-containing contraceptives, have an increased risk of developing a thrombolic event. However, a greater increase in the risk of such events compared to users of combination oral contraception has thus far not been determined to be present in the more than 5 million women who have used Ortho-Evra®. Unfortunately, the assumption that will be made by many who read the new package insert language, the van den Heuvel et al. study and the resulting press releases is that the transdermal patch is associated with an even higher rate of adverse events because the "area under the (estrogen) curve" was greater than that observed with vaginal ring or oral contraceptive use. Indeed, a recent article in the Wall Street Journal reports that numerous physicians and clinics are actually encouraging women to consider other contraceptive options or to discontinue the use of the patch altogether. Why would clinicians do this without any clinical evidence of an increased risk of adverse events? And why would an organization or agency communicate such information knowing full well the likely response of many women's health care providers?

The article concludes:

[T]here is one fundamental fact that must be in the forefront of contraceptive study and practice: without epidemiological data to support a clinical correlation, outcomes from surrogate marker studies can result in poor clinical practice. The irony is that the women who should be the beneficiaries of these package inserts changes actually become the unknowing victims of poor clinical practice. Recommendations made in the absence of data on clinical outcomes may lead to choices that increase the likelihood of unintended pregnancy.

In addition to the potential harm of using surrogate markers to develop warning statements concerning the risks associated with the patch or any other contraceptive option, another potential adverse outcome of continuing this practice is the eventual loss of confidence in our regulatory agencies and professional organizations to provide accurate information for professionals and consumers alike. The continuing inappropriate use of nonclinical studies to formulate warnings about the safety of contraceptives and other drugs may result in an interpretation to disregard these warnings by professionals and the public that will obscure real clinical risk associated with a particular drug or device. The true risks may be obscured by the continuing barrage of innuendo and pseudo-science on the package inserts of many drugs and devices.

Reproductive Health Risks

Interesting article on reproductive risks by Dr. Trussell in Contraception. [Not sure if you can access the article without a subscription, so I'll quote in full.]:

Volume 73, Issue 5, Pages 437-439 (May 2006)

Reproductive health risks in perspective

James Trussell

Beth Jordan

Dramatic headlines about women's health — deaths of women using the OrthoEvra patch, for example, or after medication abortion — can quickly lead patients and healthcare practitioners into a state of panic and uncertainty over the appropriate course of action to take. Should therapy be continued or not? What is the real risk of death?

Alarmist, misleading, inaccurate or incomplete media coverage is certainly a source of confusion, but such stylized reporting is not likely to be eliminated from most large media outlets in the near future. That fact, coupled with the lack of courses in biostatistics and risk-assessment analysis in most medical training programs and the reality that health professionals have little time to counsel patients about the risks of various treatments, can lead patients to make poor health-related choices.

This danger is particularly worrisome when patients are dealing with contraceptive issues and the threat of an unplanned pregnancy. Doctors, nurses and other providers have little time to investigate and consolidate risk-related information for their patients, and patients have few resources available to help them ascertain the risks from using various contraceptive methods. The brief summary provided here is intended to help inform clinicians and their patients of the risk of death from pregnancy, abortion and the use of various forms of hormonal contraception, as well as from other voluntary activities.

In general, contraceptives pose few serious health risks to users. Moreover, the use of contraceptive methods is generally far safer than pregnancy. Unintended pregnancies unnecessarily place women at risk. Women in many developing countries will experience an even greater advantage in using contraceptive methods than those in the developed world in comparison with pregnancy-related mortality. Nonetheless, use of some contraceptive methods may entail potential risks.

• Use of the method may lead to serious outcomes such as death, hospitalization, surgery, medical side effects, infections, loss of reproductive capacity or pain.

• Contraceptive failure (pregnancy) is associated with risk: a woman must assess the likelihood of contraceptive failure and the dangers that a pregnancy would pose.

• Future fertility may be influenced by choice of a contraceptive method.

When it comes to the most serious outcome of all — death — the absolute level of risk is extraordinarily low for most women. Table 1 puts into perspective some of the risks of everyday life in the United States [1–9]. Other major health risks from contraceptive use are not only uncommon, but they are also most likely to occur in women who have underlying medical conditions.

Table 1.

Everyday risks in perspective

	Activity	Risk of death	Source
	Risk per year
	While skydiving	1 in 1000	Laudan [1]
	From an accident	1 in 2900
	From an automobile accident	1 in 5000
	From a fall	1 in 20,000
	From a fire	1 in 50,000
	From riding your bicycle	1 in 130,000
	In an airplane crash	1 in 250,000
	From being struck by lightning	1 in 2,000,000
	Risk per year for women preventing pregnancy
	Using OCs		Schwingl et al. [2]
	Nonsmoker
	Aged 15–34 years	1 in 1,667,000
	Aged 35–44 years	1 in 33,300
	Smoker
	Aged 15–34 years	1 in 57,800
	Aged 35–44 years	1 in 5200
	Undergoing tubal sterilization	1 in 66,700	Escobedo et al. [3]
	Risk per year from using tampons	1 in 5,734,000	Hajjeh et al. [4]; U.S. Census Bureau [5]
	Risk from pregnancy	1 in 8700	Berg et al. [6]
	Risk from spontaneous abortion	1 in 142,900	Saraiya et al. [7]
	Risk from legal induced abortion
	Mifepristone/misoprostol	1 in 110,000	Summers [8]
	Surgical	1 in 142,900	Bartlett et al. [9]
	≤8 weeks	1 in 1,000,000
	9–10 weeks	1 in 500,000
	11–12 weeks	1 in 250,000
	13–15 weeks	1 in 58,800
	16–20 weeks	1 in 29,400
	≥21 weeks	1 in 11,200

Pregnancy

The risk of death from pregnancy and delivery is about 1 in 8700, lower than the annual risk of death from an automobile accident but higher than the annual risk of death from use of combined oral contraceptives (OCs) for all women except those aged 35–44 years who smoke and higher than the risk of death from abortion, even at gestational ages ≥21 weeks.

Combined OCs

Combined OCs have been associated with an increased risk of myocardial infarction (MI) and stroke. Smoking definitely increases the risk of MI, especially in women older than 35 years. However, nonsmoking, normotensive, nondiabetic women of any age who use combined OCs are not at increased risk for MI. The risk of stroke in nonsmoking women younger than 35 years is not increased by use of OCs with less than 50 μg of estrogen [10]. The risk of venous thromboembolism is increased by combined OC use, but the absolute risk of this increase is quite low among women who use OCs with less than 50 μg of estrogen, ranging from 9 events per 100,000 women-years of exposure among those aged 20–24 years to 18 events per 100,000 women-years of exposure among those aged 40–44 years [10].

Use of combined OCs is associated with a decreased risk of cancers of the endometrium and ovary and an increased risk of cancer of the cervix and liver, a small increased risk of breast cancer in young women and a decreased risk of colorectal cancer [10]. However, there is great uncertainty regarding the causal link, if any, between combined OC use and liver and colorectal cancer [10], and recent evidence suggests no association between current or former combined OC use and breast cancer [11]. Regardless, the net effect of pill use on cancer is negligible [10].

Persistent infection with certain types of human papillomavirus (HPV) is the most frequent cause of cervical cancer. However, the incidence of cervical cancer is increased in women using OCs, particularly long-term users, even among women infected with HPV; this risk increases as duration of use increases [12]. Results from limited data also suggest a slight increase in the risk of cervical cancer among women who use injectable contraceptives for 5 years or longer [12].

Analysis of pooled data from 54 epidemiologic studies conducted in 25 countries found that women have a slightly increased risk (about 25% higher) for having breast cancer diagnosed while they are using OCs. Cancers diagnosed in these women are less advanced clinically than those diagnosed in women of the same age who have never used OCs [13]. The increased risk is apparent soon after pill use begins but does not increase with duration of use, declines after use ceases and does not persist beyond 10 years after exposure ceases. These patterns are not typical for a carcinogenic agent but would be consistent with promotion of already existing tumors or with earlier diagnosis of breast cancer in women who have used the pill. A more recent study in the United Sates found that among women aged 35–64 years, current or former combined OC use is not associated with an increased risk of diagnosis of breast cancer [11].

OrthoEvra patch

The OrthoEvra patch has been recently highlighted in the press after the Food and Drug Administration (FDA) announced a label change in October 2005. The change includes a bolded "warning" indicating that use of the patch entails a 60% higher exposure to estrogen than use of a typical combined OC containing 35 μg of estrogen; however, the FDA states that the clinical relevance of this finding is unknown [14].

The actual risk of death from patch use is impossible to determine. Spontaneous reports of deaths of women using the patch have been received by the FDA. Spontaneous reports to the FDA can come from various sources, and the quality and extent of the information reported vary considerably. It is often unclear whether a death is causally related to use of a drug. Moreover, even if the intensive follow-up was to establish that a certain number of deaths were likely to have been caused by use of that drug, there remains the problem of computing an accurate mortality rate because the relevant denominator is also not known. Therefore, it is not possible to know at this time how the mortality risk from use of the patch compares with that from use of combined OCs [15].

Abortion

The risk of death is about the same from medication abortion and from surgical abortion; however, the risk of death from surgical abortion is greatest for higher gestational ages where medication abortion is not used. Nevertheless, induced abortion is safer than continuing pregnancy and entails about the same risk as spontaneous abortion.

Conclusion

As sensationalized news reporting becomes more common and thoughtful analysis becomes more difficult to find, given its perceived lack of appeal to media observers, healthcare practitioners must intensify efforts fully and repeatedly to inform patients of their true risks of death from various contraceptive methods. This imperative is particularly important as the FDA has become extremely sensitive regarding drug safety warnings.

Women are far more likely to die from pregnancy-related complications, from automobile accidents or from a fall than they are from using hormonal contraception or having undergone either a medication or surgical abortion. Those who claim that hormonal contraception and abortion are unsafe base this assertion on ideology, not evidence-based science. The evidence in Table 1 shows otherwise.

References

1. Laudan L. The book of risks. New York: John Wiley and Sons; 1994;.

2. Schwingl PJ, Ory HW, Visness CM. Estimates of the risk of cardiovascular death attributable to low-dose oral contraceptives in the United States. Am J Obstet Gynecol. 1999;180:241–249. Abstract

3. Escobedo LG, Peterson HB, Grubb GS, Franks AL. Case-fatality rates for tubal sterilization in U.S. hospitals, 1979–1980. Am J Obstet Gynecol. 1989;160:147–150. MEDLINE

4. Hajjeh RA, Reingold A, Weil A, Shutt K, Schuhat A, Perkins BA. Toxic shock syndrome in the United States, 1979–1996. Emerg Infect Dis. 1999;5:807–810. MEDLINE

5. U.S. Bureau of the Census . Statistical abstract of the United States: 2003. Washington (DC): Government Printing Office; 2003;[Table 11].

6. Berg CJ, Chang J, Callaghan WM, Whitehead SJ. Pregnancy-related mortality in the United States, 1991–1997. Obstet Gynecol. 2003;101:289–296. MEDLINE

7. Saraiya M, Green CA, Berg CJ, Hopkins FW, Koonin LM, Atrash HK. Spontaneous abortion-related deaths among women in the United States — 1981–1991. Obstet Gynecol. 1999;94:172–176. MEDLINE

8. Personal communication from Danco Laboratories, C Summers. 9 March 2006.

9. Bartlett LA, Berg CJ, Shulman HB, et al.. Risk factors for legal induced abortion-related mortality in the United States. Obstet Gynecol. 2004;103:729–737. MEDLINE

10. Burkman R, Schlesselman JJ, Zieman M. Safety concerns and health benefits associated with oral contraception. Am J Obstet Gynecol. 2004;190(Suppl):S5–S22. Abstract

11. Marchbanks PA, McDonald HG, Wilson HG, et al.. Oral contraceptives and the risk of breast cancer. N Engl J Med. 2002;346:2025–2032.

12. [12]Smith JS, Green J, Berrington de Gonzalez A, et al.. Cervical cancer and use of hormonal contraceptives: a systematic review. Lancet. 2003;361:1159–1167. Abstract

13. Collaborative Group on Hormonal Factors in Breast Cancer . Breast cancer and hormonal contraceptives: collaborative reanalysis of individual data on 53,297 women with breast cancer and 100,239 women without breast cancer from 54 epidemiological studies. Lancet. 1996;347:1713–1727. MEDLINE

14. Ortho-McNeil Pharmaceutical. Ortho Evra Product labeling. Revised November 2005.

15. Media report on Ortho Evra patch sets off safety concerns in women. Contracept Technol Update. 2005;26:113–115.